Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
Disampaikan pada:
In-Depth Training
Regulatory Impact Asessment
APPNIA; Jakarta 12 April 2017
Regulatory Impact Assessment:
Vs. Phenomena of Chasing Zero
*)
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Notes :
Keamanan Pangan?
• kondisi dan upaya yang diperlukan untuk mencegah
pangan dari kemungkinan cemaran biologis, kimia, dan
benda lain yang dapat mengganggu, merugikan, dan
membahayakan kesehatan manusia serta tidak
bertentangan dengan agama, keyakinan, dan budaya
masyarakat sehingga aman untuk dikonsumsi. (UU No
18/2012)
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
2
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Notes :
Keamanan Pangan?
• kondisi dan upaya yang diperlukan untuk mencegah
pangan dari kemungkinan cemaran biologis, kimia, dan
benda lain yang dapat mengganggu, merugikan, dan
membahayakan kesehatan manusia serta tidak
bertentangan dengan agama, keyakinan, dan budaya
masyarakat sehingga aman untuk dikonsumsi. (UU No
18/2012)
Food safety?
• Reasonable certainty of no Harm (FD&C Act)
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Notes :
How safe is
safe enough?
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.id
… Notes :
How safe is
safe enough?
… Notes :
How safe is
safe enough?
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
4
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.id… Notes :
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.id… Notes :
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
1. Transparan (~informasi)
2. Terbuka (~ keterlibatan)
3. Konsensus dan Tidak Memihak
4. Efektif dan Relevan
5. Koheren ( ~ harmonisasi)
6. Dimensi pengembangan
Prinsip Pengembangan Standar/Regulasi
No Kategori Pelaksanaan berdasarkan hasil survey
Rekomendasi
1 Transparan • 18,33% responden: tidak mengetahui prosedur • 34,43% responden: sulit
mendapatkan info • 40,91% responden yang
mengetahui dari web
Publikasi via website agar mempermudah
2 Keterbukaan • 40% responden belum dilibatkan dlm pantek
• 18,64% tidak pernah dimintai masukkan
• 54,39% belum aktif mengusulkan standar
Optimalisasi peran semua stakeholder melalui asosiasi
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
6
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.id 3 Konsensus dan Tidak Memihak• 43,33% responden tidak dilibatkan pengambilan keputusan
• 55,56% responden: hanya sebagian aspirasinya diterima • Perbedaan penilaian antara
pemerintah dan industri (terkait proporsi pengambilan keputusan)
Buat mekanisme yang menjamin bahwa semua masukan berbagai instansi dipertimbangkan 4 Efektif dan Relevan • 28,85% responden: hanya sebagian standar yg diterapkan • 53,33% responden: kendala
penerapan krn keterbatasan lab uji • 98,28% responden: kesehatan
adalah faktor utama
Perlu dilakukan kajian dampak dan kesiapan
infrastruktur RIA
Prinsip Pengembangan Standar/Regulasi
No Kategori Pelaksanaan berdasarkan hasilsurvei
Rekomendasi
Sumarto., Hariyadi, P. dan Purnomo, E.H. 2014. Kajian Proses Perumusan Standar dan Peraturan Keamanan Pangan di Indonesia. PANGAN, Vol 23 No. 2 Juni 2014. Hal 108-119
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id 5 Koheren •32,76% dan 18,96% responden:
cukup dan kurang memperhatikan peraturan/standar lain di dalam negeri
•74,65% responden: Codex sebagai rujukan utama Jika data di Indonesia belum tersedia, menggunakan standar Codex sbg rujukan utama 6 Dimensi pengem-bangan
•Seluruh responden: faktor
pengembangan bahan baku lokal, pengembangan UMKM,
peningkatan daya saing produk Indonesia penting diperhatikan
Pengembangan bahan baku lokal, UMKM, peningkatan daya saing produk Indonesia dijadikan pertimbangan dalam perumusan standar
Prinsip Pengembangan Standar/Regulasi
No Kategori Pelaksanaan berdasarkan hasilsurvei
Rekomendasi
Sumarto., Hariyadi, P. dan Purnomo, E.H. 2014. Kajian Proses Perumusan Standar dan Peraturan Keamanan Pangan di Indonesia. PANGAN, Vol 23 No. 2 Juni 2014. Hal 108-119
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.id TMS MS Standar Deviasi Garis mutu Standar
Standar/Regulasi dan “Pembangunan”
Populasi produk pangan yang memerlukan pembinaan mutu Standar Deviasi Garis mutu Standar
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
8
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.id Standar Deviasi Pembinaan Akan mendorong TMS MS Garis mutu StandarStandar/Regulasi dan “Pembangunan”
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
Standar/Regulasi dan “Pembangunan”
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
SNI (2000)
CFU : 10
6Tidak memenuhi SNI
?
Contoh Kasus: SNI Susu Segar
In 1997 the European Commission proposed a
uniform/harmonized standard for total aflatoxins, setting the
acceptable level of the contaminant in food products
(European Commission, 1997).
• 4 ppb in cereals, edible nuts, dried and preserved fruits, and
groundnuts intended for direct human consumption, and
• 10 ppb in groundnuts subject to further processing.
• 0.05 ppb for Aflatoxin M1 in milk.
The harmonized standard for the European Union is tighter
than those which have been applied in most member countries
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
10
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
Maximum allowable aflatoxin levels in Europe and Africa
(ppb)
[T. Otsuki et al. / Food Policy 26 (2001) 495–514]Case of Aflatoxin
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
Case of Aflatoxin
Maximum allowable aflatoxin levels in Europe and Africa
(ppb)
[T. Otsuki et al. / Food Policy 26 (2001) 495–514]Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
*applies to cereals & cereal products, nuts not subject to further processing, & dried fruit
Case of Aflatoxin
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
12
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.idCase of Aflatoxin
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.idCase of Aflatoxin
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
Case of Aflatoxin
• “Milder” calculation: $450 million annual loss to ALL food
exporters if ALL nations harmonized to EU aflatoxin standard
(Wu, 2004)
• Strict aflatoxin standards can have severe economic impacts
• “A World Bank study has calculated that the European Union
regulation on aflatoxins costs Africa $670 million each year
in exports of cereals, dried fruit and nuts. And what does it
achieve? It may possibly save the life of one citizen of the
European Union every two years…
• Surely a more reasonable balance can be found.”
--Kofi Annan, former UN Secretary General
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
14
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
• “Milder” calculation: $450 million annual loss to ALL food
exporters if ALL nations harmonized to EU aflatoxin standard
(Wu, 2004)
• Strict aflatoxin standards can have severe economic impacts
• “A World Bank study has calculated that the European Union
regulation on aflatoxins costs Africa $670 million each year
in exports of cereals, dried fruit and nuts. And what does it
achieve? It may possibly save the life of one citizen of the
European Union every two years…
• Surely a more
reasonable balance
can be found.”
--Kofi Annan, former UN Secretary General
… RIA : Effective vs Efficient
RIA
… Key word
RIA
Purwiyatno Hariyadi phariyadi.staff.ipb.ac.id… Framework?
• What, in general terms, is the problem to be
addressed?
• What is the specific policy objective to be
achieved?
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Framework?
Impact?
• What groups in society are being affected;
• What is the size of each group;
• What is the nature of the impact on each
group;
• How large are these effects;
• How long will these effects persist?
… Framework?
Cost?
• Buying new equipment needed to comply with regulations;
• Employing additional staff to work on regulatory
compliance;
• Employing consultants or other sources of expertise to help
with regulatory compliance;
• Changes in production processes made necessary by
regulations;
• Other increases in the costs of producing goods;
• Collecting and storing information that the regulations
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
16
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Framework?
Cost? Analysis?
• Risk/Benefit analysis
• Benefit/cost analysis
• Break even analysis
• Cost-effectiveness analysis
• Which of the possible ways of achieving the regulatory
objective has the lowest cost?
• If regulation (or policy action) is to proceed, which
option is preferable?
• Etc???
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Framework?
Cost? Analysis?
Clearly outline the benefits and costs expected
from the regulatory proposal for each group;
• Administrative
• Economic
• Social
• Environmental
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Framework?
Cost? Analysis?
Data Collection?
• Literature reviews
• Review of experience in other countries
• Other government agencies
• Business Test Panels
• Consultation with Stakeholders
• Surveys
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
18
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
Purwiyatno Hariyadi
Purwiyatno Hariyadi
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
20
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
Purwiyatno Hariyadi
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• ALOP ?
• ALARA ?
… Example? Cost? Analysis?
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
22
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• ALOP ?
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id Table 4: Weekly fish
consumption amounts required to reach PTWI of 1.6 μg/kg bw at various methylmercury
concentrations.
… Example? Cost? Analysis?
• ALOP ?
… Example? Cost? Analysis?
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
24
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• ALARA ?
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• ALARA ?
• ALARA : As Low as Reasonably Achievable
• Case of “Irreducible level”
that concentration of a substance (hazard)
which cannot be eliminated from a food
without involving the discarding of that food
altogether, severely compromising the
ultimate availability of food supplies
… Example? Cost? Analysis?
• ALARA ?
• ALARA : As Low as Reasonably Achievable
• The phrase refers to a principle of keeping
hazards in food as low as can be achieved,
based on technologic and economic
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
26
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• ALARA ?
= f(ALOP)
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• ALARA ?
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• Other: Risk/Benefit ratio?
… Example? Cost? Analysis?
Hariyadi, P. 2017. Regulatory Impact Assessment. Presentasi disampaikan pada In-Depth Training “Regulatory Impact
Asessment”. APPNIA; Jakarta 12 April 2017 ___________________________________ phariyadi,staff.ipb.ac.id
28
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
… Example? Cost? Analysis?
• Other: Chasing zero ?
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id